• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device hexokinase, glucose
Regulation Description Glucose test system.
Product CodeCFR
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIATRON US, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 13 13
2018 8 8
2019 10 10
2020 4 4
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 17 17
High Test Results 14 14
Non Reproducible Results 5 5
Incorrect Or Inadequate Test Results 4 4
False Reading From Device Non-Compliance 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 17 17
No Known Impact Or Consequence To Patient 17 17
No Clinical Signs, Symptoms or Conditions 5 5
No Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Horiba Instruments Inc II Feb-02-2016
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
-
-